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CyTuVax starts its Phase 2 BE RESPONDER! study

Effective vaccination for persons that do not respond to standard Hepatitis B vaccines

Press release

23-02-2017

Maastricht, The Netherlands, 23 February 2017 – a life science company focusing on the development of novel vaccines, today reported the start of a phase 2 study assessing the efficacy and safety of its lead product HBAI20, a hepatitis B vaccine for non-responders. Non-responders are persons who failed to build up sufficient immune protection even after receiving 6 vaccinations with a standard vaccine. Results of the phase 1 study showed that the HBAI20 vaccine induced protective immunity against hepatitis B in 90% of the non-responders. The study also showed that the safety and toxicity profile of the HBAI20 vaccine was comparable to that of a standard hepatitis B vaccine. This exciting result will now be built upon in the BE RESPONDER! study with 140 non-responders.

The HBAI20 vaccine is intended to fulfil a high unmet medical need among persons requiring protective titers against hepatitis B. Five percent of the population is unable to generate protective levels of antibody titers. These non-responders are not protected against infection with the hepatitis B virus that can result in a chronic and fatal disease. Most at risk of contracting hepatitis B are healthcare workers due to potential exposure to body fluids containing hepatitis B virus. Patients who can also benefit are transplant recipients, HIV, diabetes, and dialysis patients.

The BE RESPONDER! trial is a double blinded multi-center international clinical trial enrolling non-responders after 3 or more hepatitis B vaccinations. They will receive either the HBAI20 vaccine or a standard hepatitis B vaccine as control. Dr. Astrid Oude Lashof, Dr. Geert Robaeys and Prof. Pierre van Damme will conduct the study and are responsible for the clinical trial centers of Maastricht University Medical Center, the Ziekenhuis Oost Limburg Genk and the University Hospital Antwerp, respectively.